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Novartis Second Quarter 2016 Results

  • Q2 net sales were flat (0% cc[1]) as Growth Products[2] offset Gleevec generic impact
    • Gilenya (USD 811 million, +17% cc) continued to grow double-digit mainly due to volume growth
    • Cosentyx (USD 260 million) grew strongly driven by its three approved indications
  • Core[1] operating income declined (-4% cc) due to generic erosion and growth investments
    • Core M&S expenses up 0.8 percentage points (cc) to 24.6% of sales, mainly driven by Cosentyx, Entresto and Alcon investments
    • Core operating income margin declined 1.1 percentage points (cc) behind investments
    • Core EPS was USD 1.23 (-1% cc)
    • Free cash flow[1] was USD 2.5 billion (+22% USD)
  • Significant positive innovation news in Q2
    • Entresto given strong Class I recommendation in US and EU heart failure treatment guidelines
    • JAMA Cardiology analysis found Entresto could prevent or postpone 28,000 US deaths per year
    • Cosentyx data showed durability of response in AS[2] and PsA[2] patients after two years; head-to-head trials vs. Humira® planned
    • Phase III trial of CDK4/6 inhibitor LEE011 in HR+/HER2- advanced breast cancer stopped early due to positive efficacy results at interim analysis
    • Full results from FLAME study reinforce superiority of Ultibro Breezhaler to Seretide® in COPD
    • Positive FDA AdCom[2] for biosimilar etanercept; biosimilar rituximab submitted in EU
  • Entresto (USD 32 million) continued to grow steadily in Q2
    • Based on positive treatment guidelines, decision was taken to increase spending significantly in H2 2016 to build a US primary care field force and add incremental medical support
    • Entresto sales expected to be approximately USD 200 million for full year 2016
  • Alcon growth plan progressing
    • Operations: Improved supply stability and reinforcing customer relationships
    • Innovation: CE Mark in Europe for Dailies Total1 Multifocal and PanOptix with UltraSert
  • 2016 Outlook:
    • Net sales expected to be broadly in line with prior year (cc)
    • Based on the increased spending for Entresto, and depending on Gleevec erosion curve, core operating income expected to be broadly in line or decline low single digit (cc)

Basel, July 19, 2016 - Commenting on the results, Joseph Jimenez, CEO of Novartis, said:
"Performance in Q2 was solid despite a full quarter of Gleevec loss of exclusivity impact in the US. We have strong innovation momentum from earlier-than-anticipated Class I Entresto guidelines, positive Cosentyx data showing durability of response in AS and PsA, the early stop of the LEE011 trial, and positive FLAME results for Ultibro. We will increase investments behind these growth opportunities, particularly Entresto, in the second half of 2016 for long-term growth."

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[1] Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.
[2] Growth Products are defined on page 2. AS = ankylosing spondylists; PsA = psoriatic arthritis; AdCom = advisory committee.
[3] Refers to continuing operations, defined on page 40 of the Condensed Interim Financial Report.